Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children International | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The objective of this prospective, real-world evidence/pragmatic study with a quality improvement program approach is to evaluate the feasibility and effectiveness of a community-engaged nutrition-focused program utilizing nutrition screening, education, supplementation and continuous follow up for children and their families.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Household | Includes eligible Children and their Caregivers | ||
| Organization | NGO Staff |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Program Feasibility | Caregiver and NGO staff program experience assessed via survey via Net Promoter Score (NPS) scored from 0 to 10 where higher score is more favorable | Baseline to 12 months |
| Growth Anthropometrics | Change in Height (cm), Head Circumference (cm), Weight (kg) and Mid-Upper Arm Circumference (MUAC) (mm) as compared to pediatric growth standards (i.e. percentiles and z-scores) | Baseline to 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Resource Utilization | Caregiver completed open ended questions to obtain the frequency of healthcare resource utilization including illness frequency, severity and related missed school/work days, where more utilization means worse outcomes. | Baseline, 6 and 12 months |
| Pediatric Quality of Life Inventory |
| Measure | Description | Time Frame |
|---|---|---|
| Nutrition Behavior | Parent completed 35-item questionnaire, where higher scores indicate higher levels for that specific eating behavior | Baseline, 6, and 12 months |
| Staff Experience Survey | Assesses caregiver experience, satisfaction, and recommendations for improvement regarding the nutrition program using a combination of closed- and open-ended questions. Closed-ended questions will use Likert-scale responses ranging from strongly disagree to strongly agree. |
Household Component
Inclusion
Exclusion
• Children who have current medical conditions requiring hospitalization: gastrointestinal tract infections or inflammatory bowel disease; active tuberculosis; acute hepatitis B or C; human immunodeficiency virus OR malignancy; cystic fibrosis; immunodeficiency syndromes, congenital abnormalities of the respiratory tract, such as lung and respiratory cilia; an unsuspected foreign body in the respiratory tract; asthma; heart abnormalities; abdominal hernias; and known metabolic disorders, renal impairment, or rheumatic diseases and diabetes
Organization Component
Inclusion
Exclusion
Not provided
Not provided
Via screening by existing community-based programming via Children International (NGO)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Becherer Children International | Contact | 207-592-4917 | cbecherer@children.org |
| Name | Affiliation | Role |
|---|---|---|
| Amy Sharn, MS, RDN, LD | Abbott | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children International | Kansas City | Missouri | 64121 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
A 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life |
| Baseline, 6, and 12 months |
| World Health Organization Quality of Life Brief Version | A 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life | Baseline, 6, and 12 months |
| Nutrient Intake | Caregiver completed 24-hour dietary recall | Baseline, 3, 6, 9, and 12 months |
| Pediatric Nutrition Risk Status via Anthropometrics | Calculated from anthropometrics measurements as compared to established standards | Baseline, 3, 6, 9, and 12 months |
| 12 Months |
| Nutrition Program Enrollment and Adherence | Enrollment and adherence to the nutrition program | 12 Months |
| Caregiver Experience Survey | Assesses caregiver experience, satisfaction, and recommendations for improvement regarding the nutrition program using a combination of closed- and open-ended questions in addition to the Net Promoter Score (NPS). Closed-ended questions will use Likert-scale responses ranging from strongly disagree to strongly agree or very unsatisfied to very satisfied. | 12 Months |